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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003757
Receipt No. R000004552
Scientific Title Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT for the prevention of thoracic duct injury at the thoracic surgery for the the esophageal cancer
Date of disclosure of the study information 2011/04/01
Last modified on 2012/11/14

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Basic information
Public title Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT for the prevention of thoracic duct injury at the thoracic surgery for the the esophageal cancer
Acronym Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT
Scientific Title Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT for the prevention of thoracic duct injury at the thoracic surgery for the the esophageal cancer
Scientific Title:Acronym Thoracic duct scintigraphy by orally administered I-123 BMIPP with SPECT/CT
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the thoracic duct imaging by orally administered I-123-labeled 15-(4-iodophenyl)-3(R,S)-methylpentadecanoic acid (BMIPP) with SPECT/CT to visualize the thoracic duct and to prevent the thoracic duct injury at the thoracic surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Rate of visualization of the thoracic duct by the thoracic duct scintigraphy.
Difference among the findings of the thoracic duct scitigraphy, the other imaging modalities, and the surgical findings.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 SPECT CT scanning after the orally administration of BMIPP 111MBq.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Preoperative patients with esophageal cancer.
Key exclusion criteria Informed consent was not obtained from the patients.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Takanami
Organization Tohoku university hospital
Division name Department of Radiology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai city
TEL 022-717-7312
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tohoku university hospital
Division name Department of Radiology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai city
TEL 022-717-7312
Homepage URL
Email

Sponsor
Institute Department of Radiology, Tohoku University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Tohoku university hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23027205
Number of participants that the trial has enrolled
Results This study included 35 consecutive patients with esophageal cancer who underwent tumor resection after TD scintigraphy. For scintigraphy, 111 MBq of BMIPP was orally administered, and static images and SPECT/CT images were obtained. On the basis of the SPECT/CT fusion images, TD was divided into the following 4 segments: cervical, upper thoracic, middle thoracic, and lower thoracic. The TD visualization was categorized into 5 grades, from grade 1 (poor) to 5 (excellent). In addition, the diagnostic accuracy of 3D TD scintigraphy for the detection of anatomical anomalies of TD was calculated using the intraoperative finding as a criterion standard.
RESULTS. The TD visualization grades for the cervical, upper, middle, and lower thoracic segments were 4.4, 3.7, 3.1, and 2.1, respectively. The TD scintigraphy demonstrated an uncommon accumulation including that in the right- or bilateral-sided mediastinum or venous angle in 6 (17%) of the 35 patients. Sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of 3D TD scintigraphy for the detection of anatomical anomalies of TD were 0.75, 0.90, 0.5, 0.97, and 0.89, respectively.
CONCLUSIONS: Three-dimensional TD scintigraphy by BMIPP is a simple and minimally invasive method for imaging the anatomical configuration of the TD and for detecting any anatomical anomalies, except in the lower thoracic segment.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 15 Day
Last modified on
2012 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004552

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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